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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K072205
Device Name VISAGE PACS/CS, RELEASE VERSION 5.0
Applicant
Mercury Computer Systems, Inc.
Beim Strohhause 27
Hamburg,  DE 20097
Applicant Contact Martin Gabler
Correspondent
Mercury Computer Systems, Inc.
Beim Strohhause 27
Hamburg,  DE 20097
Correspondent Contact Martin Gabler
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/08/2007
Decision Date 08/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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